Failure Investigation

“Treating the root cause, not the

symptoms”

KarlVahey
Karl Vahey
Vice President Manufacturing
Senior Director
Quality
EMEA, LATAM, APAC and
Regulatory Compliance
Corporate Regulatory Compliance
International, Covidien
 Agenda
Importance of failure investigation. Why?

• Industry performance

• Failure Investigation steps

• Investigation Tools & Examples

• Good Investigation Practices

• Lessons learned

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 Why?

Let us paraphrase

21 CFR 820.90, Nonconforming product

21 CFR 820.100, Corrective and Preventive Action

21 CFR 820.198, Complaint Files

“LEGAL….YOU HAVE TO!”

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 Why?

21 CFR 820.90, Nonconforming product

Each manufacturer shall establish and maintain procedures to control

product that does not conform to specified requirements. The
procedure shall address the identification, documentation, evaluation,
segregation, and disposition of nonconforming products. The
evaluation of nonconformance shall include a determination of the
need for an investigation and notification of the persons or
organizations responsible for the nonconformance. The evaluation
and any investigation shall be documented’.

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 Why?
21 CFR 820.100, Corrective and Preventive Action

a. Each manufacturer shall establish and maintain procedures for

implementing corrective and preventive action. The procedure shall include
requirements for:

(2) Investigating the cause of non conformities relating to product,

processes and the quality system’.

21 CFR 820.198 (b), Complaint Files

Each manufacturer shall review and evaluate all complaints to determine whether
an investigation is necessary. When no investigation is made, the manufacturer
shall maintain a record that includes the reason no investigation was made and
the name of the individual responsible for the decision not to investigate’.

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 Why?

21 CFR 820.198 (c), Complaint Files

‘Any complaint involving the possible failure of a device, labeling, or

packaging to meet any of its specifications shall be reviewed,
evaluated and investigated’.

21 CFR 820.198 (d), Complaint Files

‘Any complaint that represents an event which must be reported to

FDA under part 803 of this chapter shall be promptly reviewed,
evaluated, and investigated by a designated individual……..’.

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 Why?
21 CFR 820.198 (e), Complaint Files
‘When an investigation is made under this section, a record of the
investigation shall be maintained by the formally designated unit identified in
paragraph (a) of this section. The record of investigation shall include:

1) The name of the device

2) The date the complaint was received

3) Any device identification(s) and control number(s) used

4) The name, address and phone number of the complainant

5) The nature and details of the complaint

6) The dates and the results of the investigation

7) Any corrective action taken and

8) Any reply to the complainant’.

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 Why?

• Our Customers Expect

o Safe, Reliable & Effective Products

• The FDA requires:

o Implementation & compliance to procedures
o Thorough investigations & testing commensurate with event & potential
impact
o Implementation & Effectiveness of all Corrective / Preventive Actions
o Review & Disposition of investigations

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 Why?

• Good Business Practice

o Process improvements
o Elimination of recurring issues
o Rework reduction
o Scrap reduction

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 Why?

Patient Safety

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FDA 2017 Top 5 483 Findings
D a t a f r o m F Y 1 7 An n u a l F D A M e d i c a l D e v i c e Q u a l i t y Sys t e m

1400

1200

1000

800
138 137 127
600 80 78 67
61
40
400

200

0
FY2017

P&PC CAPA DES MGMT DOC

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FDA Warning Letters with CAPA Cite
D a t a f r o m F Y 1 7 An n u a l F D A M e d i c a l D e v i c e Q u a l i t y Sys t e m

Year Number of WLs

FY2017 33
FY2016 75
FY2015 128
FY2014 107
FY2013 172
FY2012 163
FY2011 131
FY2010 79

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 How is Industry performing ?

FDA observations indicate:

1. Inadequate investigations

2. Lack of investigation

3. Failure to determine true root cause

4. Inadequate Corrective and Preventive Action

5. Lack of documentation

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 Industry trends
SO WHY IS THIS HAPPENING?

• Inaccurate problem statement

o Symptoms are addressed but not the actual problem
o The quick fix!

• Incomplete/Lack of a documented investigation

o Root cause not established

• Inadequate/ incomplete effectiveness checks

• Timeliness

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 Failure Investigation
Key components

1. Problem Statement

• How, what, when, where, why, who?

• Determine the scope of problem (i.e., plant, division, facility, shift, machine,
product code)

2. Containment, correction, communication, assess Risk

3. Identify root cause

4. Identify & implement Corrective & Preventive Actions

5. Horizontal deployment

6. Effectiveness verification

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 Failure Investigation
Ask
• What is known?
• What data/facts are needed?
• What tools should be used?
• What is the sense of urgency?
• What is the timeline for
resolution?
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Consider
• Any similar events reported or
known?
• Complaints, Trend Reports
• Across Corporation – Globally
• Does the problem affect:
o Other products?
o Other processes?
o Other facilities?
o Other suppliers or
manufacturers?
 1. Identify problem statement

“The formulation of a problem is the most

essential part of problem solving”

Albert Einstein

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 Problem Statement
What is a ‘problem’?

When what happened is different than what should have happened

What is a problem statement?

Concise, yet complete definition of a problem.

Why is a problem statement important?

Necessary for the investigation

Clearly identifies & describes the problem you are trying to solve

Avoids guesswork

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 Defining the Problem Statement
Answers the following questions:

• What is the product or process involved?

• Where was the issue discovered?

• When was the issue discovered?

• Who discovered it?

• Why is it a problem?

• How was the issue discovered?

Focuses on the difference Includes measurable

between actual and and
expected objective evidence
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 Example

Complaints have been received indicating an issue with Pulse Oximeters.

Complaint trends indicate that there is an issue with audio failures on Pulse
Oximeters.

The complaint data from XXX to XXX demonstrates a trend in audio failures
related to the main PCB board, PN 56983, of the X2312 Pulse Oximeters.

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 2. Assess Risk

1. Patient RISK Assessment

2. Health Hazard Evaluation (HHE) to evaluate field (post market)

product performance; evaluate hazards and score health hazards
based on likelihood of occurrence, probability of injury, and
severity of injury.

3. Consult with Medical Practitioner

4. Decide on Product CONTAINMENT

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 3. Root cause analysis

The identifiable factor(s), based on

objective evidence, which has (have)
been determined to be responsible for
the nonconformity, trend, or aberrant or
unexpected result.

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 3. Root cause analysis continued

Root cause traps

1. Equipment failure
“It just broke”

2. Human error
Procedure is inaccurate, training is current, the employee
made a mistake

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 3. Root cause analysis continued
3. Take a Broad Investigation Perspective
• Any similar events reported or known?
4. Complaints / NCMRs / Repairs / Trend reports
5. Evaluate IMPACT on:
• Other lots / product already distributed
• Other products
• Other processes
• Other facilities
6. Quality System
7. Other suppliers or manufacturers

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 3. Root cause analysis continued
8. Investigation Tools & Examples

• FTA (Fault Tree Analysis)

• Failure Mode and Effects Analysis (FMEA)

• Cause & Effect and Fishbone technique

• 5 WHYs

• 8D Approach

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 Fault Tree Analysis
Undesired state of a system ( top event) is analyzed using Boolean
logic
Visually models logical relationships between:

• equipment failures,

• human errors,

• and external events

Can combine to cause specific non-conformances

A more sophisticated form of the 5 Whys

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 Fault Tree Analysis (Example)
Bulb
Fails

No Glass Filament Vacuum

electricity Broken Broken Leak

Power Plant Power Line Connector

Impurities Vibrations
Fails Fails Corroded

Wind Breaks Tree Breaks

Line Line

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Cause and Effect Diagram (Ishikawa)

Method Measurement Machine

Head of the fish
is the focused
problem

Smaller ‘Bones’ give

root cause

Larger ‘Bones’ give

Materials Environment People main possible cause

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 Cause and Effect Diagram (Ishikawa)
People
Ask : How the behavior of the people could have caused the problem?
Material
Ask : How the material/information used could have caused the problem?
Machine
Ask : How the machine/equipment/infrastructure used could have caused
the problem?
Method
Ask : How the method/instruction used could have caused the problem?
Environment
Ask : How the operating environment could have caused the problem?
Measurement
Ask : How the measurement taken could have caused the problem?

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 5 Why Analysis

Ask the 5 WHY questions to find the root cause of the problem

1. Ask - Why did the problem occur

2. Ask - Why did 1 cause the problem
3. Ask - Why did 2 cause the problem
4. Ask - Why did 3 cause the problem
5. Ask - Why did 4 cause the problem

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 5 Why example
Problem Statement:
You are on your way home from work and your car stops in the middle of the road.

1. Why did your car stop?

- Because it ran out of gas.

2. Why did it run out of gas?

- Because I didn't buy any gas on my way to work.

3. Why didn't you buy any gas this morning?

- Because I didn't have any money.

4. Why didn't you have any money?

- Because I lost it all last night in a poker game.

5. Why did you lose your money in last night's poker game?

- Because I'm not very good at "bluffing" when I don't have a good hand.
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 5 Why example
Problem statement:
Product X was mislabeled

1. Why was the product mislabeled?

- Because the wrong component was put in a tray

2. Why was a wrong component put in the tray?

- Because the component was left over from a previous lot

3. Why was a component left over from a previous lot?

- Because line clearance was not performed

4. Why was line clearance not performed?

- Because there is no requirement to verify line clearance activities

5. Why is there no requirement to verify line clearance activities?

- Because …….

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 8D Technique

- Problem-solving methodology for product and process improvement

- Structured into eight disciplines, emphasizing team synergy.
- Use Team Approach
- Describe the Problem
- Implement and Verify Short-Term Corrective Actions
- Define and Verify Root Causes
- Verify Corrective Actions
- Implement Permanent Corrective Actions
- Prevent Recurrence
- Congratulate Your Team

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 5. Identify & Implement CAPA
Record investigation & identify root cause

 Identify & agree actions

 Document the planned method of effectiveness for the agreed

actions

 Implement actions

 Approve completion of actions

 Perform Effectiveness checks

 Evaluate & Close CAPA

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 Good Investigation Practices
Good Executive Summary:

 Clear & succinct Problem Statement

 Description of the depth of the problem

 Risk level assessed

 Brief chronology of significant events in the investigation

 Actions and conclusions that are supported by facts

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 Failure Investigation Lessons learned

• Stopping too soon in the process

• Not asking the why enough times-not getting to the true root cause

• Incomplete investigation

• Factors not considered / documented

• Associated lots not identified / evaluated

• Absence of root cause not justified

• Conclusions not supported by data

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 Failure Investigation Lessons learned

• Jumping to quick conclusions

• Does the investigation file contain opinions, assumptions, and

guesses?

• Not having the “right” people involved

• DOCUMENTATION!

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 Conclusion
Ensure:

 Accurate problem statement

 Complete and documented investigation

 True root cause

 Adequate effectiveness checks

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 Q&A

Thank you

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